Industry News

One-Stop Solution for Sterile Packaging of Medical Devices

Medical devices, particularly those that directly or indirectly come into contact with a patient's blood, sterile tissues, or mucous membranes, such as surgical knives, catheters, and implants, must be sterile. If the packaging is damaged or improperly sealed during transportation and storage, microorganisms (such as bacteria and fungi) can infiltrate, leading to contamination of the devices. Using contaminated devices may cause infections and even pose a threat to patients' lives. CIRS Testing offers a comprehensive suite of solutions for sterile packaging of medical devices, including microbiological, chemical, accelerated aging, physical and mechanical property, and transportation testing. This ensures patient safety and helps your products comply with regulations to enter global markets!

EU MDR Regulation Requirements for CMR/EDCs Substances

According to the EU MDR Regulation, Appendix I General Safety and Performance Requirements (GSPR) Article 10.4 regarding CMR/EDCs substances: The design and manufacture of medical devices should minimize the risk caused by substances or particles (including swarf, degradation products, and processing residues, etc.) that may be generated by the device. These substances mainly refer to CMR and EDCs substances.